Replies to post #35916 on Amarin Corp Plc (AMRN)

[Invest83838]

HDGabor, Your Example is Unfortunately Spot On

Since the FDA is both the buyer and the entity that grants the "necessary permission", as well as the entity that changes the regulation, in your example, the system is rigged against the seller Amarin. And that is how the FDA, as well as other branches of the federal government, has become the monstrosity it is today.

[ziploc_1]

The SPA made no mention of Vascepa having to show a reduction in CV events. They mentioned only that Vascepa would be judged on its ability to reduce triglycerides, It did this successfully and WITHOUT SIDE EFFECTS. If the FDA wanted proof, beyond a reasonable doubt, that Vascepa would reduce CV events, they should have mentioned this in the SPA but they refrained from doing so. Either an SPA has some meaning or it DOES NOT.

[Whalatane]

HD
Actually a questionable example, having been involved in multiple real estate deals .

Buyer and Seller would agree on the terms of the CONTRACT.
...You ( The seller / AMRN ) are to get an approved design , the permits , work completed as permitted , lien releases to prove everyone was paid in full AND the building dept signing off as project completed as designed and permitted ...

You have a CONTRACT that provides for penalties if you ( Amarin )do all this AND the buyer ( FDA ) fails to complete the purchase

If Amarin followed all these steps ...whats the penalty for the FDA ?
None
Why ...understand the difference between an agreement and a contract
Kiwi

[biowreck]

Unfortunately, it's quite obvious that the FDA is not accountable for its actions and is omnipotent. This agency has the power to make the rules and change them on the fly. It's no better than a third world dictatorship. It seems crazy that the only way to introduce and market a drug in the good ol US of ObamA has to go through this sham.

[jessellivermore]

Dear HD...

There are several errors in your post.


"SPA isn't about approval, it's about the study and (in this case) the condition to submit the sNDA."

Of course the SPA is about approval. The SPA is simply a written contract spelling out a quid quo pro agreement between the sponsor and the FDA under what conditions the FDA will grant the mixed dyslipidemia indication. The conditions were a satisfactory trig reduction in ANCHOR and a FDA approved outcome trial (REDUCE-IT) "substantially underway".
The only conditions by which the FDA could legally breach this contract would be new (after the the commencement of the trial) scientific evidence that indicated the drug was unsafe, or ineffective.

Your second paragraph does not make sense.

"Its somewhat like the prospective buyer (the FDA) telling a prospective seller(Amarin); "I will buy your house on the condition that the seller puts a mountain of money into it to fix it up and assume that all necessary permission will be granted. Then, after Amarin spends a fortune on the house, The FDA says; "I want the necessary permission before I buy, because regulation was changed and I did not get the permission in case of other seller/ house."

In this case it would be the buyer (the FDA) who is issuing the permissions, ie is also the regulator.. In America were call this "judge and jury". The real issue in the SPA rescission is the FDA has not met the agreed upon terms. The FDA may very well have changed its mind about surrogate markers and trigs, but this is not a condition of the agreement. The pre specified conditions do not require proof that trigs will lower CVD risk in statin patients. Indeed if it were known or universally agreed that trigs either would reduce CVD risk as an add on, or would not reduce risk as an add on, what would be the purpose of an outcomes study. The whole point of running REDUCE-IT was to answer the question, will trig lowering by Vascepa as a statin add on lower CVD risk.

There is another issue in this matter. Did the FDA act in good faith? The fact the FDA now admits it had concerns over the trig add on hypothesis going back to 2010. The question is why did not they just tell Amarin they were changing their mind and call the whole thing off before Amarin spent over a hundred million dollars on the trial. Why did they delay until after the eleventh hour, and spring this on them a few weeks before they were scheduled to grant the SNDA label change?

Also if the FDA has proof that the trig lowering add on with Vascepa is futile, why did they not tell Amarin to stop the trial...The reason is obvious..the FDA does not know the answer and wants to find out. At the very least, the FDA should be reimbursing Amarin for the cost of REDUCE-IT.

":>) JL